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NICE demands more data from Roche for MabThera in rare autoimmune disease

Unable to recommend expanding drug’s indication to include vasculitis

Roche MabThera rituximab

Roche needs to provide more data backing the use of MabThera in a rare autoimmune condition before it can be considered for use on the NHS in England and Wales.

The UK's National Institute for Health and Care Excellence (NICE) issued draft guidance saying that, based on current evidence, it could not approve MabThera (rituximab) for use in adults with a type of inflammation of the blood vessels called anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, explained that the independent committee to assess the cost-effectiveness of the drug in this new indication found “gaps and uncertainties” in the information provided by Roche.

“The next step is for the manufacturer to respond to the committee's comments and submit further information as requested,” she said.

This required extra information includes further data to show MabThera's long term benefits in the condition, as well as a revised economic model, which must include comparison treatment in the management of severe ANCA-associated vasculitis.

Roche also needs to define what constitutes a severe disease in this indication, with ANCA-associated vasculitis an umbrella term for several related conditions, some more severe than others.

On top of this, NICE wants Roche to define what circumstances under these conditions is it preferable to avoid treatment with current vasculitis therapy cyclophosphamide, which can have serious side effects.

If Roche complies with these instructions and the drug does gain approval, the company would be able to extend MabThera's market in the UK to reach the estimated 1,200 people diagnosed with ANCA-associated vasculitis each year in England and Wales.

However, this is a relatively small market in comparison to its current cancer and arthritis indications, with MabThera recommended by NICE for use in the treatment of chronic lymphocytic leukaemia, follicular lymphoma, non-Hodgkin's lymphoma and rheumatoid arthritis.

23rd July 2013

From: Sales

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